May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of a First Amendment lawsuit by affected parties” if it does not consider medical textbooks to be “educational materials that directly benefit patients” which are excluded from a reporting requirement under the final rules implementing the Physician Payment Sunshine Act, according to a May 15 letter to CMS from the Washington Legal Foundation (WLF).
In its letter (CMS Textbook Policy), WLF asks CMS to delay application of reporting requirements to medical textbooks until it has had an opportunity to examine the First Amendment implications of including these items as “transfers of value” from manufacturers to doctors.
Coalition for Healthcare Communication (CHC) Executive Director John Kamp remarked that the WLF letter “is strong, balanced, nuanced and likely to be effective. Indeed, if WLF convinces CMS to reverse itself on textbooks, the same reasoning applies to journal supplements, reprints and Website publications that are distributed with company support.”
Specifically, WLF contends the following in its letter:
- The distribution of medical textbooks is speech protected by the First Amendment;
- Although CMS is not banning speech, it is substantially burdening speech (and such burdens are subject to First Amendment constraints);
- The Sunshine final rule’s disclosure requirement imposes a substantial burden on the right to speak by distributing medical textbooks;
- Application of the Sunshine Act to medical textbooks does not serve any substantial government interests; and
- CMS can avoid First Amendment difficulties by construing the Act as inapplicable to medical textbooks.
“Applying the reporting requirements to medical textbooks would constitute a serious infringement on the First Amendment rights of pharmaceutical companies to disseminate medical texts and the First Amendment rights of doctors to receive such information,” WLF Chief Counsel Richard A. Samp wrote in the letter to CMS Acting Administrator Marilyn Tavenner.
“The U.S. Supreme Court has repeatedly held that disclosure requirements of this sort [imposed by the final rule] are subject to ‘exacting scrutiny’ and can pass muster under the First Amendment only if shown to serve important government interests that outweigh the burdens they impose on speakers,” the letter states.
The WLF also states that the burden of reporting and doctors’ concerns about being included on a list of those receiving payments from drug companies will cause doctors to decline offers of medical textbooks and cause companies to cease disseminating them. Because medical textbooks communicate truthful information that helps doctors treat patients, the WLF asserts that they are fully protected by the First Amendment, as demonstrated by multiple U.S. Supreme Court decisions. “By all accounts, medical textbooks supplied by drug companies to doctors ‘directly benefit patients’ – doctors regularly use information gleaned from the textbooks in their treatment of patients,” according to the WLF.
As further evidence that medical textbooks constitute protected speech under the First Amendment, the WLF states that its 1998 lawsuit against the Food and Drug Administration (FDA) resulted in the FDA being subject to a permanent injunction limiting FDA authority to suppress manufacturer dissemination of medical textbooks discussing off-label uses of their FDA-approved products.
“There is little evidence that Congress intended to single out textbook dissemination and other expressive activities for special disapprobation, but the effect of the Act (as interpreted by CMS) is to burden this expressive activity to such an extent that much of the activity will cease,” the WLF letter states. Samp concludes the letter by stating that “in light of the grave constitutional issues raised by CMS’s rule, courts will not defer to CMS’s reading of the Act … even if they deem it a plausible reading,” and advises CMS to reconsider and allow these educational materials to be excluded from reporting requirements.
“Exempting these as educational items not only makes sense under the Sunshine Act, it makes great public policy sense,” CHC’s Kamp said. “Informing doctors about the latest science and practice guidelines drives improved patient care. Everyone can salute that result.”
May 6, 2013 — With Sunshine Act reporting slated to begin in less than three months, it is sobering to note that many physicians and investigators still are unaware of the regulation, a majority are not in favor of making information about physician-industry financial relationships available to the public, and a small percentage would consider not engaging in clinical trials to avoid a perception that they are too involved with one sponsor.
A recent study conducted by Industry Standard Research (ISR), “Sunshine Act: Pharma Impact – Changes in U.S. Physician Behavior,” found that physicians are worried that the Sunshine Act will have a negative effect on their practice. ISR surveyed physicians and other stakeholders affected by the Sunshine Act. Of 103 physician respondents, 74 percent said they were not in favor of sharing these data; 18 percent of the 100 investigators surveyed said they would stop participating in some clinical trials if they started to do “too many” trials for one sponsor, as reported in a recent article in Policy and Medicine (http://www.policymed.com/2013/05/physician-payment-sunshine-act-principal-investigators-and-primary-care-physicians-largely-unaware-of-regulation-1.html).
“If physicians are concerned that interacting with the pharmaceuticals industry has a negative connotation, there could be a chilling effect on those relationships, which are vital to the public health,” said Coalition for Healthcare Communication Executive Director John Kamp. “The Sunshine Act is supposed to lend transparency to these relationships, not undermine them.”
Although the report states that “few physicians believe the rule will have an impact on how they treat patients,” 38 percent of physicians and surveyed say that they are not at all familiar with the Sunshine Act and 23 percent of principal investigators surveyed state that they have never heard of the Sunshine Act.
As part of the study, ISR researchers evaluated physicians’ frequency of use and the value they place on specific communications channels, as well as which channels might be less likely to be used following Sunshine Act implementation. “While the channel expected to be impacted most significantly is ‘group/practice-level detail sessions’ where doctors and their staff typically receives free lunches, we did see a 12-percent drop in the level of interaction expected across all ‘in-person’ activities,” said Andrew Schafer, ISR president.
Indeed, the report states that the Sunshine Act “will have a dramatic impact on the ability of pharma sales representatives to frequently detail physicians, both one-on-one and in a group setting.” The report adds that although 47 percent of physicians indicated that they participate in a group detail on a weekly basis currently, only 30 percent said they plan to continue this practice after the Sunshine Act requirements kick in.
Interestingly, 71 percent of physician respondents stated that they expect pharmaceutical companies to inform them of the value of a service or benefit prior to it being offered to them. However, even though physicians are worried about the potential negative publicity surrounding their interaction with pharma companies, they “mention that they use pharma sales representatives as a key source of information for new medicines and treatments.” One physician quoted in the report said the Sunshine Act rules “will reduce availability to new information about existing and new products.”
“These findings support the fact that industry needs to do all it can to ensure that context regarding the industry-physician relationship is provided and included in press reports about the data that ultimately will be made public,” Kamp said. “The Coalition raised this issue in comments to the Centers for Medicare & Medicaid Services, and we cannot stress enough that getting this point across will make a huge difference in the public’s perception of this information. We have to make clear that these relationships are crucial to keeping physicians informed and to ensuring that patients receive the most effective treatments for their conditions.”
For details on the ISR survey report, go to: http://isrreports.com/industry-reports/sunshine-act-pharma-impact-changes-in-us-physician-behavior
Nov. 19, 2012 – At its recent Interim Meeting, the American Medical Association’s (AMA’s) House of Delegates voted to clarify the AMA’s ethical guidance on continuing medical education (CME), according to a Nov. 16 posting on Policy and Medicine. The AMA’s Council on Ethical and Judicial Affairs (CEJA) made revisions that are consistent with many industry standards – such as codes established by AdvaMed and the Pharmaceutical Research and Manufacturers of America (PhRMA) – as well as the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support.
“The AMA did the right thing here by encouraging physicians to participate in continuing education programs
that meet existing ACCME and PhRMA guidelines,” said Coalition for Healthcare Communication Executive Director John Kamp. He indicated that the AMA should have gone a step further to recognize the value of other industry-supported education, including REMS and other education sessions regulated by the FDA. “But it’s still a good step forward,” Kamp remarked.
Policy and Medicine’s Thomas Sullivan, who is president and founder of the medical education company Rockpointe Corp., told the Coalition that “physicians and patients have greatly benefited from educational programs supported by industry. This ethical opinion shows AMA’s continued commitment to companies contributing back
to medicine by supporting accredited CME.”
Sullivan added that “it is helpful for physicians to not have confusion between the ACCME and AMA, and these changes by CEJA bring the AMA ethical opinions in line with the ACCME Standards for Commercial Support.”
To view the full Policy and Medicine article, go to: http://www.policymed.com/2012/11/ama-ceja-ama-house-of-delegates-passes-clarification-to-align-with-accme-standards-for-commercial-su.html
2012 – Pharmaceutical and medical device companies may be allowed to provide “modest meals and refreshments” at non-continuing medical education (CME) events in Massachusetts if proposed “emergency amendments” to the state’s law covering codes of conduct for these industries are adopted. An Oct. 19 hearing is planned to discuss the amendments.
In July, state legislators passed revisions to the 2008 Pharmaceutical and Device Manufacturer Code of Conduct (PCOC) as part of the 2013 state budget.
The Massachusetts Public Health Council last week set forth an exception to the 2008 gift ban that would allow meals to be offered at non-CME presentations for healthcare professionals outside of the office or hospital setting.
The amendments set forth the following definition: “Modest Meals and Refreshments, food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged
by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.”
The amendments also include the following provisions:
- Pharmaceutical or medical device manufacturing companies and agents may provide or provide payment for modest meals and refreshments to health care practitioners outside of the health care practitioner’s office or hospital setting for the purpose of educating and informing health care practitioners about the benefits, risks and appropriate uses of prescription drugs or medical devices, disease states or other scientific information, provided that such presentations occur in a venue and manner conducive to informational communication. For the purposes of 105 CMR 970.006(3), “appropriate uses” may not include the promotion of off-label uses of prescription drugs or medical devices.
- No pharmaceutical or medical device manufacturing company may provide or provide payment for such meals and refreshments permitted under 105 CMR 970.006(3) unless such pharmaceutical or medical device manufacturing company files quarterly reports detailing all non-CME educational presentations at which such meals or refreshments are provided. Reports shall include:
- the location of the non-CME presentation;
- a description of any pharmaceutical products, medical devices or other products discussed at such presentation;
- the total amount expended on such presentation; and
- an estimate of the amount expended per participant, factoring any meals, refreshments or other items of economic value provided at such presentation.
The amendments, which the Council has asked to be adopted on an emergency basis, also allow “for transparency through federal disclosures published in a searchable database by the DPH allowing monitoring of manufacturer conduct.”
The proposed amendments do not change the code of conduct regarding meals related to CME. The current provision stipulates that pharmaceutical or medical device manufacturing companies may not provide “payment for meals directly to a health care practitioner at any CME event, third-party scientific or educational conferences, or professional meetings, although a CME provider or conference or meeting organizer may, at its own discretion, apply any financial support provided by a pharmaceutical or medical device manufacturing company for the event to provide meals for all participants.”
According to the Massachusetts Public Health Council, the proposed amendments for non-CME events:
- Are consistent with nationally recognized standards included in industry codes of conduct;
- Promote educational and training opportunities;
- Implement legislative intent to balance consumer protection, the legitimate interests of pharmaceutical and medical device manufacturers, and promoting the education of health professionals; and
- Include a definition of modest meals and refreshments that does not include a specific dollar limit.
In addition to holding the Oct. 19 hearing, the Massachusetts Department of Public Health will be accepting written comments on the proposal. The regulation will be voted on by the Council at its Nov. 14 meeting and will be filed with the Secretary of the Commonwealth. The final regulation will be effective as published on Dec. 7.
“We are working with PhRMA and other allies on how best to participate in the upcoming Oct. 19 hearing,” said Coalition for Healthcare Communication Executive Director John Kamp. “Indeed, we are looking for input from members in comment form and would particularly like to hear from our members in Massachusetts.”
Oct. 3, 2011 – In
his recent Drugwonks blog, Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, suggests that attempts to separate clinicians, medical researchers and drug companies may not be in patients’ best interests. “We must dismantle the battlements and embrace [a] philosophy of ‘symbiosis not schism.’ It’s what’s in the best interest of the patient,” Pitts explains in “Peering Over the Health Cliff.” To read the full article, go to: http://www.drugwonks.com/blog_post/show/7952
Dec. 14, 2011 — UPDATE — CMS has published the proposed rules enforcing the Sunshine provisions of the Affordable Care Act. See related materials on the site for details and instruction on how to comment on these proposals by the February 17, 2012 deadline.
Meanwhile review a recent column on the Sunshine Act appearing in Communiqué, Coalition for Healthcare Communication Executive Director John Kamp stated that “without adequate protection, complying with the Sunshine Act could damage our relationships with doctors and patients as well as endanger the improved patient care that results from collaboration.” He adds that “the days of avoiding sunshine and public scrutiny of industry-doctor relationships in the United States
To read the full column, go to: http://www.communiquelive.com/features/archive/2011/september/dont_get_burnt
Free registration may be required to access the piece.
March 28, 2011 – The Coalition for Healthcare Communication (CHC) and other stakeholders warned government regulators that they must be very careful to limit the scope of regulations that enforce the new “Sunshine Act” to avoid a serious regulatory burden on both the government and industry. Regulators also need to avoid sending a signal to the press and the public that collaboration between the medicines and device industries and medical providers is inherently bad, they asserted.
Indeed, the CHC strongly believes such collaborations improve patient care by providing enhanced communications that result in better use of medicines and devices with patients. Accordingly, Coalition Education Foundation Executive Director Jack Angel participated in last week’s call held by officials at the Centers for Medicare & Medicaid Services (CMS) to seek guidance on how to best implement Section 6002 of the Affordable Care Act. Section 6002 creates a national registry of gifts and payments to physicians, i.e., public reporting of payments/transfers made by manufacturers and group purchasing organizations of medical products covered by Medicare and Medicaid to physicians and teaching hospitals.
During a CMS Open Door Forum held March 24 to collect stakeholder input regarding that implementation, entitled “Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests,” Barbara Cebuhar, CMS Office of External Affairs, explained that CMS is working toward the publication of a draft regulation in 2011. She asked that call participants provide “insight and experience” on how to best craft transparency provisions.
“Transparency is appropriate,” the CHC’s Angel said, but only when financial relationships are not portrayed negatively, and when the data provided publicly are accurate and are put in the proper context. It’s also important that the costs of compliance are as low as possible in order to avoid increasing the cost of medical products.”
Similar views were expressed by many industry stakeholders, who raised concerns about any potential expansion of the categories of payments and asked that CMS set clear requirements, allow for stakeholder review of any data before public dissemination and establish technological requirements for submission, review and correction.
“The process is already quite onerous,” said Michael D. Seidman, M.D., otolaryngology/ENT, at the Henry Ford Medical Group in the Detroit area. “Regulations should not further stifle innovation,” Seidman remarked.
Industry to CMS: No Expansion Necessary
In response to the first questions posed by CMS – whether other forms of payment or transfers of value should be considered as part of the draft regulation – several commenters stated that they were not aware of any need to expand the category, and that any expansion would be redundant.
Marjorie Powell, senior assistant general counsel at PhRMA, said that CMS should carefully consider the amount of transaction data that will be required to be collected, aggregated and reported under the currently defined forms of payment. “CMS is going to be inundated with transaction data. We have heard from one mid-size pharmaceutical company that it would expect to report up to one million transactions involving approximately 300,000 physicians in the first year alone.”
Requirements should be “very clear and simple for manufacturers to use and for CMS to compile,” Powell added, and should include a master list of teaching hospitals and physicians for whom payments must be reported. “Given the complexity of the statute as written, we encourage CMS to focus on getting proposed regulations prepared rather than on expanding the universe,” she said.
CMS also asked call participants to provide input on the definitions of the nature of payment or transfers of value and whether the agency should consider more than the 14 types of payment specified slot machines online for real money in the legislation or whether additional categories of information should be reported. Doug Petticord, executive director, Association of Clinical Research Professionals (ACRO), told CMS that ACRO’s answer “largely would be ‘no,’” and that it was “hard to see what additive value would be brought by new categories.”
Public Should Receive Contextual Information
A question from CMS about which types of information should be reported to the public and how it can maximize the use of collected information on its Website was met by industry comments about appropriate context for consumers. Sandi Dennis, deputy general counsel for BIO, advised CMS to include objective background for consumers, directed at targeted consumer audiences.
“We recommend that the agency conduct focus group research and consult with experts to ensure that the information provided is clearly defined and explained,” Dennis said, and that it is “useful and not misleading.” CMS also should consider creating a task force of industry members, providers and public advocates to help establish what contextual information should be included on the Website, she said.
Julie Cohen, vice president, governmental affairs, for AdvaMed, stated that although AdvaMed supports disclosure about relationships between medical technology companies and physicians, the organization wants to “ensure that consumers get accurate information,” including clear background information about why these relationships exist and benefit patients. “For example, physicians themselves are often the inventors of new technology. Other physicians provide valuable feedback, research and technical expertise to improve existing technology,” Cohen said.
“It’s also important to emphasize that physicians receive critical training both from companies and other skilled physicians so they can use and operate medical technology safely and effectively,” Cohen told CMS. “AdvaMed believes that the information provided in the public database should emphasize how these interactions contribute to continued medical advances in technology and to providing safe and effective medical care.” She also noted that companies should be permitted to provide additional context surrounding payments in the database, so that “patients can better understand the relationships that exist.”
Several other commenters requested that CMS work to ensure that the requirements neither stifle innovation nor chill relationships between companies and physicians. Also addressed was establishing a defined pathway for all entities to correct any data errors before information is publicly disseminated. Technical considerations, such as CMS possibly designing submission templates and providing data that is searchable and downloadable, also were presented.
CMS has made a recording of the call available until midnight on March 28. It can be accessed by calling 1-800-642-1687 and referencing conference number 51513536. CMS also is accepting written comments sent to the following e-mail address through April 7 at: email@example.com.
Although 2011 brings political party shifts in Congress and new challenges, the mission of the Coalition for Healthcare Communication (CHC) remains the same: To protect, for society and individual patients, the benefit of the free flow of healthcare information. This year the CHC will be focusing on four major issues: (1) tax treatment of marketing costs; (2) “transparency,” conflict of interest and collaboration; (3) proposals to limit the collection and use of Rx and consumer medical data; and (4) FDA DDMAC’s policies and guidelines (including social media guidelines). The 2011 Focus of the Coalition describes the issues CHC will be tracking in 2011, the political climate in which those issues will be debated and how potential outcomes could change the Rx communication business and affect the public health.
With the amount of negative attention lately surrounding relationships between physicians and industry, some doctors have had enough. In response to the recent criticisms, Bradley P. Knight, MD, FACC, FHRS, Editor-in-Chief of the Electrophysiology Lab Digest, wrote an article defending the “Legitimate Relationships Between Physicians and Industry.”
Read a summary of the article in Tom Sullivan’s Policy and Medicine blog. Sullivan includes a link to the full text of Dr. Knight’s article.
In one of her final acts as NJ Attorney General, Anne Milgram’s office has issued a new report, “Physician Compensation Arrangements,” recommending limitations to physician-industry relationships for state agencies that go above and beyond guidelines outlined by PhRMA and other organizations.